A prospective multicenter clinical study on the accuracy evaluation of urine exosomal phospholipid markers in the diagnosis of hepatocellular carcinoma

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200065653

Enrollment

Unknown

Registered

2022-11-10

Start date

2022-11-10

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Gold Standard:Gold standard: biopsy or surgical excision of liver mass lesions or extrahepatic metastases, diagnosed as hepatocellular carcinoma by histopathological and/or cytology.

Index test: urine exosomal phospholipid markers

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (satisfies both a and b, and conforms to either of c-f) a) signed informed consent; b) The length of stay at the first visit is greater than 1 day; c) the diagnosis of hepatitis B and hepatitis C meets the Diagnostic Criteria for Chronic Hepatitis B (2015 Edition) and the Diagnosis of Hepatitis C (WS 213-2018, respectively); d) The diagnosis of alcoholic hepatitis is in line with the Guidelines for the Prevention and Treatment of Alcoholic Liver Disease (2018 Update), and the diagnosis of non-alcoholic steatohepatitis is in line with the Guidelines for the Prevention and Treatment of Nonalcoholic Fatty Liver Disease (2018 Update). e) The diagnosis of liver cirrhosis is in line with the "Guidelines for the Diagnosis and Treatment of Liver Cirrhosis" formulated by the Hepatology Branch of the Chinese Medical Association. f) People with a family history of liver cancer.

Exclusion criteria

Exclusion criteria: (Any of the items a-e conform) a) be younger than 18 years of age or older than 80 years; b) Diagnosis of liver cancer or liver metastases upon admission; c) Presence of other serious comorbidities, such as heart failure, chronic kidney disease, stroke within the past six months, severe autoimmune disease or metabolic disease d) pregnant women; e) Long-term use of immunosuppressants.

Design outcomes

Primary

Measure	Time frame
Joint diagnostic indicators of sphingomyelin, phosphatidylcholine and phosphatidylglycerol;sensitivity;Specificity;	—

Countries

China

Contacts

Public ContactXiaozhong Wang

The Second Affiliated Hospital of Nanchang University

wangxzlj@126.com13576041466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026